The revised ICH E14 Question and Answer (R3) document issued in December 2015 enables pharmaceutical companies to use concentration‐QTc (C‐QTc) modeling as the primary analysis for assessing QTc prolongation risk of new drugs. A new approach by including the time effect into the current C‐QTc model is introduced. Through a simulation study, we evaluated performances of different C‐QTc modeling with different dependent variables, covariates, and covariance structures. This simulation study shows that C‐QTc models with ΔQTc being dependent variable without time effect inflate false negative rate and that fitting C‐QTc models with different dependent variables, covariates, and covariance structures impacts the control of false negative and false positive rates. Appropriate C‐QTc modeling strategies with good control of false negative rate and false positive rate are recommended. 相似文献
An analysis of 184 in-depth interviews with grown children of Korean and Vietnamese immigrants finds that the racial beliefs, meanings, and stereotypes of the mainstream society shape how they think about coethnics, generate local identities, and deflect stigma from themselves. We examine the terms FOB (Fresh Off the Boat) and whitewashed that were commonly deployed to denigrate coethnic others as too ethnic or too assimilated while casting those at the bicultural middle as the normals. We describe how this system of intraethnic othering serves as a basis for sub-ethnic identities, intraethnic social boundaries, and the monitoring and control of social behavior. We draw on the concept of internalized racial oppression in framing our findings. 相似文献
This paper examines the issue of horizontal inequalities in Vietnam over the past 20 years. Using data from three recent Vietnam population censuses (1989, 1999, and 2009) and three Vietnam Household Living Standard Surveys (1998, 2008, 2012), we estimated numerous measures on inequalities between five groups against four welfare indicators. Our results show that horizontal inequality matters in Vietnam, in particular for ethnicity, region, and rural/urban groups. While there has been an improvement in horizontal inequality in education, this paper shows little change in other welfare indicators, in particular poverty. We also found that horizontal inequality does matter for poverty reduction in Vietnam and it needs more attention when designing poverty policies in the future.